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August 26, 2020

Human Genetics and Drug Development

Please read the attached article in preparation for participating in this Week’s Discussion Board – given the discussion in the article, as well as the material in Reading Assignments that address genetic heterogeneity please opine on how the drug discovery and biopharmaceutical product development process can be improved to better support evaluations of safety and efficacy for these products. For example, should the approved indication(s) for use for new biomedical products be constrained to specific populations in which genetic analysis has been thoroughly analyzed as part of the clinical development process? Should all piviotal Phase III clinical trials be limited in scope with respect to the genetic composition of patients included within the study? Please justify your responses with course material and/or examples from the primary literature.

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